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3201
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2735
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461
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2285
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773
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958
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System, Image Processing,...
725
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671
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533
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System, Imaging, Pulsed Doppler,...
533
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Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
431
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
386
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Manufacturers
US
Carl Zeiss Meditec, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Carl Zeiss Meditec, Inc. - FDA 510(k) Cleared Devices
29 submissions
·
29 cleared
·
Since 1993
Official Website
29
Total
29
Cleared
0
Denied
29
devices
26-29 of 29
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1
2
Cleared
May 01, 2003
STRATUSOCT WITH RNFL NORMATIVE DATABASE
K030433
·
HLI
Ophthalmic
·
80d
Cleared
Jun 26, 1995
ANGIOSCAN (AS STAND ALONE INSTRUMENT)
K951132
·
HLI
Ophthalmic
·
105d
Cleared
Jul 18, 1994
NERVE FIBER ANALYZER
K941705
·
HLI
Ophthalmic
·
103d
Cleared
Mar 26, 1993
TOPOGRAPHIC SCANNING SYSTEM TOPSS
K923742
·
HLI
Ophthalmic
·
242d
1
2
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29
Ophthalmic
25
Radiology
3
General & Plastic Surgery
1